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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030035 / PAS001 |
| Date Original Protocol Accepted |
05/13/2004
|
| Date Current Protocol Accepted |
|
| Study Name |
Long term
|
| Device Name |
ANTHEM AND FRONTIER II CRT-P'S
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This study was designed to collect, characterize and report on the performance of the device system through three years post-implant.
|
| Study Population |
The study included patients rolled over from the pre-market study and newly enrolled post-approval study patients.
|
| Sample Size |
1,121 patients, 46 sites
|
| Key Study Endpoints |
Endpoints include all-cause mortality for patients implanted with CRT-D or CRT-P systems; Freedom from left ventricular lead or left ventricular lead implant procedure related adverse events; Electrical performance of the left ventricular leads
|
| Follow-up Visits and Length of Follow-up |
Patients will be followed every six months for 3 years.
|
| Interim or Final Data Summary |
| Interim Results |
Study completed, see final results.
|
| Actual Number of Patients Enrolled |
1127 patients
|
| Actual Number of Sites Enrolled |
46 sites
|
| Patient Follow-up Rate |
73%
|
| Final Safety Findings |
The freedom from all-cause mortality for patients implanted with CRT-D systems is 80% at 3 years. The freedom from LV lead or procedure-related complications is 94% at 3 years. The freedom from system-related complications is 89% at 3 years. The reviews by the lead reviewer and clinical reviewer show that these rates are consistent with expectations and that the 20% mortality is not unexpected given the high proportion of class III and IV heart failure patients.
|
| Study Strengths & Weaknesses |
Strength: Large sample size which allows for the examination of rarer events Limitation: Allowance for inclusion of IDE study participants. There was a substantial difference in the major outcomes (death, HF events, etc) between the subjects who were rolled in from the IDE and the newly enrolled PAS subjects (who faired notably worse). This substantial difference seems to be independent of the covariates that were looked at and so it may be concerning. One likely explanation for the difference is of selection bias. The subjects rolled in from the IDE had already been free of death and presumably major events before they enrolled in the PAS and so may have been overall less likely to have events compared to the newly enrolled subjects. But even if selection bias explains the difference, it seems to me that the results for the newly enrolled subjects is a better representation of real world outcomes.
|
| Recommendations for Labeling Changes |
None
|
